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I’m unclear on whether this drug is approved in the EU for Ichthyosis. The source says it was first in compliance, and later out of compliance and laid out certain actions that were taken, but I can’t figure out whether it’s still approved. The only information I can find is it being approved for the treatment of acne in the EU. Ben❯❯❯Talk00:38, 18 May 2021 (UTC)[reply]
Where did you get the information that it is approved at all in the EU? The source only shows the orphan drug designation documents. --ἀνυπόδητος (talk) 07:35, 18 May 2021 (UTC)[reply]
This seems to indicate it has been approved. I'm not familiar with the EU's procedure for approving drugs, but it seems that each country has to also approve it. Another source hereBen❯❯❯Talk03:29, 24 May 2021 (UTC)[reply]
You are right. I didn't know that decentralised approvals are still a thing; these apparently don't show up on the EMA page. In this process, the individual countries indeed have to approve it separately, in contrast to centralised approvals, where this isn't necessary. --ἀνυπόδητος (talk) 11:10, 24 May 2021 (UTC)[reply]